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EP2610010A1 - Support de collecte de preuves pour analyse automatique de prélèvement - Google Patents

Support de collecte de preuves pour analyse automatique de prélèvement Download PDF

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Publication number
EP2610010A1
EP2610010A1 EP13160889.5A EP13160889A EP2610010A1 EP 2610010 A1 EP2610010 A1 EP 2610010A1 EP 13160889 A EP13160889 A EP 13160889A EP 2610010 A1 EP2610010 A1 EP 2610010A1
Authority
EP
European Patent Office
Prior art keywords
absorbent
holder
handle
collection
cover
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP13160889.5A
Other languages
German (de)
English (en)
Other versions
EP2610010B1 (fr
Inventor
Jangbir S. Sangha
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SANGHA, JANGBIR S.
Bode Cellmark Forensics Inc
Original Assignee
Bode Technology Group Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bode Technology Group Inc filed Critical Bode Technology Group Inc
Publication of EP2610010A1 publication Critical patent/EP2610010A1/fr
Application granted granted Critical
Publication of EP2610010B1 publication Critical patent/EP2610010B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/505—Containers for the purpose of retaining a material to be analysed, e.g. test tubes flexible containers not provided for above
    • B01L3/5055—Hinged, e.g. opposable surfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A61B90/96—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text using barcodes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/50273—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the means or forces applied to move the fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0064—Devices for taking samples of body liquids for taking sweat or sebum samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/18—Transport of container or devices
    • B01L2200/185—Long distance transport, e.g. mailing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/021—Identification, e.g. bar codes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/069—Absorbents; Gels to retain a fluid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0887—Laminated structure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00—Supporting devices; Holding devices
    • B01L9/52—Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N2001/002—Devices for supplying or distributing samples to an analysing apparatus
    • G01N2001/007—Devices specially adapted for forensic samples, e.g. tamper-proofing, sample tracking
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N2001/028—Sampling from a surface, swabbing, vaporising

Definitions

  • the field of the present invention is devices for collecting biological samples.
  • the several embodiments of the present invention provide a device having an absorbent for collection of oral fluids or blood specimens or cells thereon.
  • Several embodiments of the specimen collection devices provide for recordation of identifying information and for division of the sample into separate identifiable portions to permit use of the specimen as law enforcement evidence.
  • the embodiments of the invention further provide a holder for containing and/or securing the original specimen collection material or paper or absorbent that was used in the actual collection of the biological specimen or sample.
  • the holder permits the original collection paper or absorbent to be processed by automated analysis equipment by securing the collection paper or absorbent in a holder that is structured to permit extraction of a test sample while maintaining the evidentiary requirements necessary for a proper chain of custody.
  • the invention allows for collecting saliva from the mouth or blood samples from a suspect or mammal or DNA samples while later permitting extraction of portions of the sample collection absorbent for testing while maintaining the chain of evidence and identification of the specimen of saliva or blood.
  • a useful form of evidence collection device for use with biological specimens will contain, at least, a suspect information portion for recording subject information data thereon.
  • biological specimens as evidence further requires that the biological specimen be securely associated with the identifying information so as to assure that after collection of the specimen, the collection paper or absorbent cannot be intentionally or inadvertently switched to a different collection paper.
  • a proper evidence collection device or holder should easily and clearly show that tampering was attempted either by damage to delicate indicia on the device or by overt damage to a strongly secured device. It is further beneficial if the evidence collection device can accommodate additional forms of evidence such as the application and storage of fingerprints on the evidence holder.
  • sample collection is often taken from a living, uncooperative person. Often the sample is to be taken from the mouth of the suspect where a saliva or DNA specimen is needed. In this instance, the collection absorbent used will be attached to a handle or a stick. Once the specimen is on the absorbent, the handle is no longer needed, a present complicating factor in specimen storage and analysis due to the extra bulk and size.
  • “chain of custody” encompasses the procedures and documentation used to maintain and demonstrate the chronological history of the evidence. Documentation should include, for example, name or initials of the individual collecting the evidence, each person or entity subsequently having custody of it, dates the items were collected or transferred, agency and case number, victim's or suspect's name, and a brief description of the item.
  • the principles of evidence or sample identification involved in maintaining proper “chain of custody” are especially critical as a fluid or cellular biological sample, once collected onto an absorbent, presents no distinguishing characteristics. This lack of visual characteristics foils any attempt to properly identify such a biological fluid or cellular sample once it has become separated from its identifying information.
  • Another problem or issue presented in the analysis of biological specimens is the need to extract or transfer the collected sample from the original collection absorbent and onto an alternate medium to permit analysis or testing of the specimen using the analysis equipment that is available in the selected laboratory. Often it is necessary to separate the collection absorbent from its originally obtained identifying information that is directly associated with the original collection absorbent. This separation of specimen from identifying information can lead to mistakes in associating the specimen with the correct subject or suspect or can lead to the "chain of custody" being open to question in court and a failure of proof of a crime. Sample misidentification is a major source of error both in laboratory analysis and in substantiating criminal evidence.
  • sample holders or specimen/sample carriage devices shown in the present application are to meet collection requirements that allow blood specimen collection or body fluid collection or DNA collection to qualify for secure evidence handling and for chain of custody proof requirements in law enforcement.
  • sample holder used for adapting the sample or specimen collection device to an automated sampling system incorporate the original specimen collection absorbent and avoid the need for any transfer of the specimen onto a second absorbent or require the transfer of a bar code or other identifying material from the collection absorbent or DNA collector or sampling device onto the sample device holder.
  • the original specimen collection absorbent and the same bar code that is attached to the original sample or specimen collection absorbent or device be inserted into the sample holder and be viewable from within the sample or specimen holder. It also is important that the absorbent or sampling paper surface, while held within the holder, be exposed so that small portions or circles can be punched from the paper for delivery into testing vials for making the DNA determination.
  • the sample holder have a locking feature so that once the sample collection device and/or absorbent is fixed within the holder, it is locked into the holder, and the holder cannot be tampered with or opened without the damage being evident. It is another benefit if the holder for such automated sampling avoids a secondary transfer of the original collection absorbent 110 ( Fig. 10 ) of collector or collection device 106 ( Fig. 10 ) or any destruction of the original sample device 106 and/or collection absorbent 110 and maintains the original collection absorbent 110 ( Fig. 10 ) attached or within its handle and bearing its original bar code marking and other identifying markings.
  • a sample carriage device embodiment 10 which allows the paper absorbent 110 of the specimen/sample collector 106 to be inserted into the carriage device 10 and the paper absorbent 110 captured within the carriage device and the paper separated from the collector handle 114 ( Fig. 10 ) by serrated edges 21 on device 10.
  • embodiment 10 is comprised of an upper portion 12 that is connected to a bottom portion 14 by the use of a hinge means or staple connection or fold along back edge 16 to permit top portion 12 to be separable from bottom portion 14 along front edge 18.
  • Front edge 18 includes cutter portion 21 having teeth-like edges or serrations in front edge 18 the purpose of which shall be described hereinafter.
  • a specimen or sample collector 106 such as the one shown in Figures 8 - 10 can be used with any of the embodiments of Figs. 1-7 .
  • Other configurations or shapes of absorbents 110 may be used if the registration track or groove 22 of the sample carriage 10 is reconfigured to accept the alternate absorbent shape.
  • the sample carriage 10 shown in Figs. 1-3 may be operated by removing the handle portion 106 from holder 108 ( Fig 10 ) and inserting collection absorbent or paper 110, having a specimen or sampler thereon, into device 10 such that absorbent or paper 110 is visible within viewing or sample collection area or window 24.
  • top portion 12 is pressed against bottom portion 14 to secure absorbent 110 therebetween.
  • Top portion 12 and bottom portion 14 are then held together by a securing means.
  • top portion 12 and bottom portion 14 are held together by a frictional fit between top portion 12 and bottom portion 14 as top portion 12 fits into a recessed area 28 of bottom portion 14.
  • the securing means may be a post 32 insertable into a detent 34 to lock together top portion 12 and bottom portion 14 as is shown in Figs 4-5 for embodiment 30 ( Fig. 4 ).
  • sample paper 110 is fixed within the holder 10, the paper may then be loaded into an automated sampling device such as an automated sample-punching machine such as a BSD-1000 manufactured in Australia.
  • the automated sampling device will read bar code 26 on top surface 12 of device 10.
  • a typical automated sampling device will then punch samples from collection paper 110 as it is held within window 24 of holder 10.
  • bar code 26 is bar code 152b shown on collection device 106 in Fig. 10 and which has been transferred to the holder 10 during the process of capturing collection absorbent paper 110 within holder 10.
  • a duplicate version of bar code 152b may be produced and placed on device 10 to serve as bar code 26.
  • Device 40 is shown which is similar in construction to device 10 of Figs. 1-3 .
  • Device or sample holder 40 is comprised of a top or upper portion 12 that is separate from bottom portion 14.
  • a securing means is provided to connect upper portion 12 to bottom portion 14 after absorbent 110 has been inserted into registration track or groove 22 of bottom portion 14.
  • the securing means is post 32 which is inserted into void or detent 34 and which is captured therein.
  • Device 40 also includes a cutter portion 21 with teeth-like edges or serrations that serve to allow the user of device 40 to tear absorbent 110 from handle 114 of collector 106 when absorbent 110 has been captured between upper or top portion 12 and bottom portion 14.
  • devices 10 and 40 may involve the transfer of the identifying bar code 152b from the handle 106 of the collection device of Fig. 10 to sample holder 10 to provide the bar code shown in the position of bar code 26.
  • sample holder 10, 40 as a unit that includes a specimen collector such as collector 106, both of which devices are pre-provided with matching bar codes 26.
  • Figs. 1-5 involve modification of the structure of the device used to collect the sample. Specifically, the handle 114 is separated from paper 110 upon which the sample resides. While the embodiments of Figs. 1-5 do not contain all the preferred features of a preferred embodiment, they will be functional for some purposes in which a chain of custody or evidentiary issues are not as strict as within criminal chain of custody matters.
  • a specimen holder 50 is shown in which the entire collection handle 114 and collection paper 110 of collection device 106 ( Fig. 10 ) is inserted into the holder 50.
  • Holder 50 is comprised of an upper portion 12 and a bottom portion 14 which can be superimposed on one another and pressed together to interconnect to capture device 106 ( Fig. 12 ) within registration groove 22 of holder 50.
  • Top portion 12 and bottom portion 14 are held together, as described for the embodiments of Fig. 1-5 , by any useful means of securing the top portion 12 to the bottom portion 14.
  • Such means may be adhesive tape, staples, ultrasonic fusing of the material together if the holder were plastic, or an arrangement of locking posts and detents can be utilized such as is shown in Figs. 6-7 .
  • posts 32 are registerable and insertably lockable into detents 34.
  • the handle 114 can be shortened, if necessary, to fit into the device by cutting the handle 114 or providing a perforation line that allows breaking handle 114 to shorten it to a length compatible with holder 50.
  • a handle sample holder 106 having a bar code 152b and having a collection absorbent or paper 110 attached thereto such as the collection device 106 of Figs. 8-10 of the present application is inserted into bottom portion or half 14 of device 50.
  • windows 52a, b and 54a, b are included on both top portion 12 and bottom portion 14 of holder 50.
  • a support band 56 bridges windows 52a, b and 54a, b. Support band 56 supports device 106 within the holder 50 while allowing the bar code 152b on device 106 to be viewed and read with a bar code scanner and sample collection portion 110 of device 106 to be exposed and accessible and viewable at all times.
  • bottom portion 12 and top portion 14 of device 50 can be constructed so the top and bottom portions are identical.
  • the individual inserting device 106 into the halves of the device need not select and match a top portion and a bottom portion. This can be achieved by simply manipulating the closure method so the top 12 and bottom 14 can be the same.
  • the posts and detents it would be possible to put all the posts on either the top or the bottom or on one edge of the device, so identical tops and bottoms could be constructed.
  • Fig. 7 In operation, after device 106 has been inserted into holder 50 and top portion 12 connected to bottom portion 14, the resulting assembly is as shown in Fig. 7 .
  • device 106 is locked within the compressed together top and bottom halves 12, 14 of device 50 and bar code 152b of device 106 is visible within window 52a and collection paper 110 is visible and accessible through window 54a, b.
  • window 54a is aligned with window 54b, a portion of collection absorbent 110 may be removed by use of a punch to extract a sample of collection paper or absorbent 110 for testing.
  • the original bar code attached to sample collection device 106 is still attached to device 106 and is visible through window 52a of device 50. Further, if additional or alternate bar code or identification symbols are needed, they may be placed on device 50 as is shown by bar code label 26.
  • Holder 60 is comprised of a holder bottom or body portion 14 to which is attached a foldable, closeable top portion or hood portion 12 and which is attached to body portion 14 at hinged edge 16.
  • Attachment point or edge 16 can be any flexible hinge type of connection between body 14 and hood 12 that permits hingeable opening of portion 12 with respect to body 14.
  • portion 12 could be a separate cover from body portion 14, and the two portions 12 ann 14 made connectable by interlocking weld means or post and detent means or other connection means as previously described for the devices shown in Figs. 1-7 .
  • the object is to contain a collection device 106 within holder 60 while presenting the identifying bar code 152b and the sample collection paper or portion 110 visible and available for reading and for the punching of sample disks from collection paper 110.
  • device 60 of Fig. 11 is used as follows.
  • a collection sample device such as device 106 of Figs. 8 - 10 is placed on bottom portion 14 so that absorbent 110 covers window 24 on bottom 14 and handle 114 of device 106 is generally flush with the surface of bottom portion 14.
  • Window 24 permits collection paper 110 to be viewed and paper disks to be punched from collection paper 110 when device 106 is mounted within holder 60.
  • window 24 of top portion 12 of the device 60 has a similar window portion 24 directly opposite and in registration with the window of top 12 and which is in base portion 14. This alignment of windows 24 permits a paper disk to be punched from collection paper 110 as absorbent paper 110 is held within device 60. Further, the disk can fall out of holder 60 through window 24 in bottom portion 14 and into testing vial or dish.
  • Device 106 is adapted for use in an automated sampling machine without the need to separate collection paper 110 from handle 114 or the need to transfer identifying bar code 152b from device 106 onto an automated sampling holder device.
  • a collection card 100 is shown having an embodiment of the specimen collection holder 150 attached thereto.
  • the specimen holder 150 may be used alone in addition to being used, as shown, attached to information portion 175.
  • Card 100 is comprised of an information portion 175 on which may be recorded the name 178, date of birth 180, sex 181, social security number 183, and other useful information regarding a suspect or convict such as the violation which qualifies for obtaining a biological specimen 184, and the date of collection 185, and the signature of the individual certifying that the offense for which the specimen was collected qualified as an offense which permitted the collection of biological information 186, and for which a blood or fluid or DNA specimen and other evidentiary information is to be obtained.
  • the specimen can be collected in the manner previously described by use of a handle portion 106 having a collection paper 110 attached thereto.
  • the paper may then be inserted into holder 150 which operates in a manner similar to the manner described previously for the embodiment shown in Figs. 1- 5 wherein the collection paper 110 attached to handle portion 106 is inserted into the holder 150 such that the paper is located in window 166.
  • handle 114 is removed through the use of serrations 152 provided with the holder 150.
  • serrations 152 provided with the holder 150.
  • collection paper 110 would be inserted into holder 150 in between upper portion or surface 154 and lower portion or surface 156, and upper surface 154 is then closed against lower surface 156 in the manner previously described herein to secure surface 154 against surface 156 and capture absorbent sample collection paper 110 therebetween using adhesive strip 160.
  • the cutter or serrations 152 may be used to separate handle 106 ( Fig. 10 ) from collection paper 110.
  • bar codes 176 are provided both on information portion 175 and on holder portion 150.
  • a bar code 176b, 176c is provided which spans across both information portion 175 (See, bar code 176b) and holder portion 150 (See, bar code 176c) such that if holder portion 150 is separated from information portion 175 by the use of perforation 158, both portions 175, 150 will contain an identical bar code identification 176 as it is printed to span perforation line 158.
  • An additional aspect of evidence that can be obtained by the use of the embodiment of Figs. 13 - 15 is a fingerprint of the suspect or convict that can be placed into fingerprint block 162 that is on holder top portion 154.
  • a law enforcement department can obtain all relevant and necessary information to identify a suspect or convict or other offender by the use of body fluid sample or DNA as well as by conventional forms of identification such as fingerprinting into block 160 and with identifying information placed into information portion 175 and a split bar code 176b, 176c correlating the physical evidence of holder portion 154 with the suspect information contained on information portion 175.
  • a separate block 164 for imprinting a state department of justice identifier also is provided.
  • Fig. 15 the reverse, side of embodiment 100 is shown, including the reverse side 190 of information portion 175 and the reverse side 200 of holder portion 150.
  • areas for marking the date the card 100 was received at various locations 194 is provided, a space for a department of justice specimen number 164, identification and signature of the collecting agent 196, the name and signature of the subject 198, and space for a second fingerprint 192.
  • the second fingerprint can further serve as a correlating marking proving that the individual whose biological sample and/or fingerprint appeared in holder 150 also was available to provide the finger or thumb print which was placed on the reverse side 190 of information portion 175.
  • a perforation line 158 is shown in the location described in the discussion of the embodiment of Figs. 13 - 15 .
  • perforation line 158 allows separation of holder portion 150 from information portion 175 as was the case for the embodiment shown in Figs. 13 - 15 .
  • the embodiments shown in Figs. 16 and 17 also contain a second perforation line 205 that serves to subdivide the sample holder 150, and the evidence contained thereon, into multiple sample portions 210, 215. This splitting of sample holder 150 into two sections 210, 215 permits separation of the biological specimen 110 ( Fig.
  • absorbent 110 Fig. 17
  • it can be split into two portions 110a and 110b. This splitting permits a portion of the identical biological sample, for example, 110b, to be sent to a laboratory for analysis while a portion 110a is retained with the information portion 175 ( Fig. 16 ) of the embodiment.
  • a bar code 176, 176b, 176c, 176c', 176d is affixed to each portion of the embodiment with some representations of the bar code 176b, 176c, 176c', 176d spanning two of the sections.
  • bar code 176b, 176c is placed across perforation 158 such that a portion of the bar code 176b, which is fully readable, remains with information portion 175, and a portion of the bar code 176c, which is fully readable, is retained with holder portion 150.
  • a second bar code 176c', 176d is placed across perforation line 205 to permit identification of both halves of holder portion 210, 215 once perforation line 205 has been used to divide holder portion 150 into two halves 210, 215. It also will be appreciated that as the holder portion 150 of embodiments 200, 200a is separable into first and second halves 210, 215 that two fingerprint areas 162a, 162b are provided on each half 210, 215 of holder portion 150.
  • bar code 176c', 176d be identical to bar code 176b, 176c and to bar code 176.
  • a separate bar code number for holder portion 215 could be cross-indexed against the bar code used for holder portion 210 as the intent is to be able to match holder portion 210 with holder portion 215 once separation using perforation line 205 has occurred.
  • a hinged embodiment could be provided which allows the sample or absorbent 110 to be split into two absorbent portions as is provided for in the embodiments of Figs. 16 and 17 .
  • FIG. 17 a variation on the embodiment of Fig. 16 is shown in which device 200a is provided with a perforation line 205 that divides device 200a into two pieces.
  • a bar code 176b, 176c is provided which is centered on perforation 205 to provide a bar code 167b, 176c with a first half 210 having bar code 176b thereon, and with a second half 215 having bar code 176c when perforation 205 is used to divide device 200a into first and second halves.
  • a portion of collection paper 110, specifically 110a, is allocated to first half 210, and a second portion of collection paper 110b is allocated to second half 215 when perforation 205 is used to divide device 200a into two pieces. If desired, additional evidence regarding the subject person can be provided in the form of fingerprints that would be applied to fingerprint area 162a, 162b.
  • Device 220a can be associated with a separate information portion 175 ( Fig. 16 ) or can be attached to an information portion 176 by use of an adhesive.
  • device 300 is comprised of handle 306a, 306b. Handle half 306b may be folded onto handle half 306a along perforation or fold or crease line 304 which permits handle portion 306b to cover and protect paper 110 which is at one end of handle portion 306a. It will be appreciated that information regarding the sample and the individual from whom the sample is taken and the time and other identifying and informational indicia may be recorded on any of the four surfaces of handle 306a, b as shown in Figs. 18 and 19 .
  • Device 300 is provided with a sampling window 308 through which paper 110 is exposed to allow the punching of a specimen of the blood drop or saliva that has been placed onto paper 110.
  • device 300 may be used for obtaining a blood sample from an animal such as by first securing the animal, followed by completion of the specimen information on side b of handle portion 306b to identify the animal.
  • handle 306a is folded against handle portion 306b such that folded to the outside. This manner of folding will present the whole of collection paper 110 for collection of the specimen with window 308 on the inside of the fold.
  • the user will place side d of handle portion 306a against the palm and swipe paper 110 against the blood drop that is formed where the animal's ear has been pricked.
  • FIG. 20 - 22 another embodiment, 400, similar to the embodiment shown in Figs. 18 and 19 .
  • Figs. 20 - 22 showing the folding together of handle 306a and 306b together and which is similar to the folding together of handle 306a, b shown in Figs. 18 - 19 for embodiment 300.
  • the embodiment of Figs. 20 - 22 is an embodiment that lacks window 308 ( Fig. 19 ) to provide access to collection paper 110. Rather, the embodiment of Figs. 20 - 22 provides greater protection for paper 110 by providing a front cover 412 and back cover 414 for paper 110 before and after the sample is taken.
  • Fig. 20 - 22 provides greater protection for paper 110 by providing a front cover 412 and back cover 414 for paper 110 before and after the sample is taken.
  • handle 406a, b of embodiment 400 is shown in the closed position with front cover 412 separated from paper 110 and back cover 414 separated from paper 110.
  • Front cover 412 and back cover 414 are made separable from paper 110 to permit paper 110 to be exposed for sample taking and to permit paper 110 to be exposed in the laboratory for punching from paper 110 of a sample for testing purposes.
  • information may be recorded on the outside of handle 406 as shown in Figs. 18 - 19 form device 300.
  • either front cover 412 or back cover 414 may be folded backwardly to fully expose paper 110 leaving the other cover in place to support paper 110 as it is rubbed against the subject for a DNA specimen collection or used to blot blood for a blood specimen.
  • the folded cover 412 or 414 can be replaced to cover and to protect the sample that has been collected onto sample collection paper 110.
  • covers 412, 414 are in the closed position, they cover and protect collection paper 110.
  • the sample can first be collected onto paper 110, followed by the closure of handle portions 406a, b by folding handle portion 406a against 406b to cover and protect collection paper 110 until the sample reaches the laboratory.
  • front cover 412 and back cover 414 can be torn away from handle 406a, b thus exposing collection paper 110 for extraction of a sample portion therefrom for use in testing.
  • Device 500 is provided with a punch window 508a, b to allow a specimen sample to be punched from specimen collection paper 110.
  • Device 500 presents a handle portion 506 having an information portion 575 thereon for use in identifying the subject, such as a particular animal.
  • the user fills in the information about the.subject animal on information portion 575.
  • the user then pricks the ear of the animal and touches paper 110 to the drop of blood that is formed on the ear.
  • the best practice in the use of device 500 is to apply sufficient blood so that the paper 110 exposed via window 508a is fully saturated with blood.
  • the blood can be applied to paper 110 from side B of handle 506 or from side A of handle 506.
  • end portion C is folded along line W and away from side A and against side B.
  • end portion C cover paper 110 on side B and paper 110 is then framed on each side of device 500 by window 508a on side A and by window 508b on side B. This allows the operator at the testing laboratory to have a clear, supported field of paper 110 from which to punch a testing sample.
  • Device 600 is a combination of an information portion 675 and a specimen holder portion 650. As previously described, information portion 675 is to be filled out at the time the specimen is being acquired. Specimen holder portion 650 contains the various pieces of evidence which are being collected such as a fingerprint in area 662 and an area for insertion of collection paper 110 (not shown) which is placed onto area 660 and to which an adhesive backed curing paper 661 is then applied to secure collection paper 110 to specimen holder 650. It will be appreciated that device 600 contains window 608a, 608b through which the laboratory may punch a testing sample from paper 110.
  • device 608 is provided with a cutter edge 667 which can be used to separate absorbent paper 110 from handle 114 ( Fig. 10 ).
  • Device 600 further contains bar code 676 that is printed across perforation 658 to provide an identifying bar code on both information portion 675 and specimen holder portion 650.
  • Device 700 is a specimen holder only which may be affixed to a separate information identification card or may simply be used within the laboratory to hold a specimen for insertion into an automatic testing device.
  • Device 700 is comprised of substantially the same features, as is device 600.
  • a bar code 776 is provided for identification of device 700.
  • a thumbprint may be applied to device 700 area 762 when device 700 is used in the field.
  • a collection paper 110 may be aligned within paper holder area 760 to cover window 708b after which an adhesive securing paper or adhesive label seal 761 is applied to secure paper 110 in holder 700.
  • Adhesive strip 761 is provided with window 708a which allows the laboratory to punch a sample from paper 110 that is secured within device 700. Again it will be appreciated that device 700 is provided with cutter teeth 767 which allows separation of paper 110 from handle 114 ( Fig. 10 ).
  • FIG. 27 Device 800 is shown in Fig. 27 in its nearly collapsed form.
  • device 800 is shown with an adhesive seal 802 removed and handles 806a, 806b partially separated from collection paper holding panel 803 and window panel 804.
  • device 800 is essentially an elongate rectangle of paper which has been folded to present four panels, to handle panels or portions 806a, 806b and paper holding panel 803 and window panel 804.
  • Examination of Fig. 29 shows that the reverse side of panel 803 from that shown in Fig. 28 contains window 808b.
  • device 800 has been expanded further from the nearly closed position shown in Fig. 27 .
  • Handle portion 806a is connected to window panel 804 that is connected to paper holding panel 803 that is connected to handle 806b.
  • an adhesive section with release liner 807 is provided which will allow the securing of handle 806a to handle 806b to prepare the device for use.
  • device 800 is shown from the reverse face of that shown in Fig. 28 .
  • absorbent paper 110 is visible through window 808b in paper holder section 803. It will also be appreciated that window 808a and at window 808b align when panel 803 is brought against panel 804 along Arrow J.
  • FIG. 30 panel 804 has been positioned against panel 803 and handle portion, or panel 806a, is about to then be positioned against handle portion 806b. It will be appreciated that adhesive release liner 807 has been removed so that handle 806a can be secured to 806b.
  • FIG. 31 device 800 is shown fully assembled with handle portion 806a adhesively secured against handle portion 806b and handle 808a aligned with window 808b to allow absorbent paper 110 to be exposed for collection and punching purposes.
  • Device 800 is then used in collection devices shown in Figs. 18 - 24 when collecting paper is applied to the pricked ear of an animal or has blood or saliva or other body fluid applied to it to collect biological specimens of the subject or animal for later testing.
  • Fig. 33 an alternate embodiment of the device shown in Figs. 25 and 26 is shown.
  • two sample storage portions 760 are shown.
  • the dual sample storage portions allow the collection agency to collect two different specimens (e.g., saliva and blood) from the same subject or duplicate samples (e.g., two saliva samples) from the same subject.
  • the specimen absorbent is secured onto portion 760 by application of an adhesive-backed cover paper 661 as previously described.
  • top layer 912 is shown in a peeled-up position to allow insertion of a collection absorbent 106 therein.
  • the top layer can be pressed against bottom layer 914 to capture the collection absorbent therebetween.
  • a releasable adhesive is used to secure top layer 912 to bottom layer 914.
  • a release liner (not shown) can be used to cover a permanent adhesive on bottom layer 914 until it is desired to secure top layer 912 to bottom layer 914 at which time the release liner can be removed to expose the adhesive.
  • the use of a release liner is preferred in situations in which it is desired to permanently secure the collection absorbent into the device 910 and to reveal any attempt to re-open the device to tamper with the absorbent once it is placed into the device.
  • DNA collection device 1200 comprises holder or holder portion 1202 having cavity 1204. Cavity 1204 is configured to accommodate handle 1216 and to allow support of DNA collection absorbent 1208 on absorbent support area 1203 at front end 1214 of holder 1202. Sliding cover 1210 is operably joined to handle 1216 to permit sliding cover 1210 to be moved over absorbent 1208 to protect absorbent 1208 and to be retracted to expose absorbent 1208.
  • Handle 1216 comprises lower handle portion 1206b and upper handle portion 1206a having DNA absorbent 1208 captured therebetween.
  • this unit of lower handle portion 1206b, upper handle portion 1206a and absorbent 1208 will be referred to as handle 1216.
  • Holder 1202 in a preferred embodiment, is configured so handle 1216 may be inserted into cavity 1204 of holder 1202 from rear end 1212 of holder 1202. Once handle 1216 is entered into holder 1202 from rear end 1212, handle 1216 then may be pressed forwardly toward front end 1214 of holder 1202 to permit absorbent 1208 to rest upon and be supported by absorbent support area 1203. As handle 1216 is inserted from rear edge 1212, and as it is pressed forwardly towards front edge 1214, outside edges 1220a,b ( Fig. 36 ) of handle 1216 are pressed underneath and frictionally captured by retaining flanges 1218a, 1218b of holder 1202.
  • the forward movement of handle 1216 within holder 1202 is ended when side stop 1222a,b and bottom stop 1224 protruding from lower handle portion 1206b contact rear end 1212 of holder 1202.
  • the frictional capture of handle 1216 by flanges 1218a, 1218b firmly retains handle 1216 within holder 1202 and positions and retains absorbent 1208 on area 1203 of front end 1214 of holder 1202 during the collection of DNA samples. It will be appreciated, as will be described hereinafter, that the secure retention of handle 1216 on holder 1202 permits the ease of sliding movement of slidable cover 1210 during the operation of the DNA collection device 1200.
  • DNA collection device 1200 is provided in two operational forms, the first being shown in Figs. 34 - 35 wherein handle 1216, having slidable cover 1210 attached thereto, is mounted in holder 1202. It is in this configuration that absorbent 1208 is resting on absorbent support area 1203 on front end 1214 of holder 1202 to thereby provide support and reinforcement of absorbent 1208 as it is used for the collection of DNA samples from a subject. As described hereinafter, the configuration of Figs.
  • holder 1202 support handle 1216 provides for support of absorbent 1208 during collection procedures and allows for the covering and protection of both top and bottom surfaces of absorbent 1208 during precollection, collection, and post-collection procedures. This configuration also allows for moisture to evaporate from absorbent 1208 when the DNA collection procedure has involved a liquid or wet sample.
  • device 1200 The second general operational form of device 1200 is shown in Figs. 36 and 37 wherein holder 1202 has been removed from handle 1216 leaving slidable cover 1210 attached to handle 1216. In this configuration, device 1200 is most conveniently used within the laboratory for manipulation of the handle 1216 during the removal of portions of absorbent 1208 for the performance of clinical testing on any sample collected on absorbent 1208. The use and operation of device 1200 while in the configuration shown in Figs. 36 and 37 will be described in detail hereinafter.
  • FIG. 34 and 35 the operation of device 1200 with handle 1216 contained in holder 1202 will be described.
  • the configuration of device 1200 as shown in Figs. 34 and 35 is primarily intended for shipping of the device to the field officer or station where a DNA sample will be collected, for actual use of the device during the collection of the DNA sample and then for a return shipment of the device to a clinical laboratory for analysis.
  • Device 1200 is particularly suited to these operations as in Figs. 34 and 35 , it can be seen that handle 1216 is contained completely within holder 1202 and is provided with slidable cover 1210 mounted atop handle 1216 as shown and described in Fig. 38 .
  • a comparison of Fig. 34 with Fig. 35 shows that in Fig.
  • slidable cover 1210 is positioned or pushed rearwardly to expose absorbent 1208 to view and to use, whereas in Fig. 35 , slidable cover 1210 is pushed or pressed forwardly so absorbent 1208 is hidden from view by slidable cover 1210.
  • Absorbent 1208 is protected from any unintentional and undesired contact with the surroundings by slidable cover 1210 protecting the top surface of absorbent 1208 and holder 1202 protecting the bottom surface of absorbent 1208. It will be appreciated that during shipping procedures and during operations prior to and after the collection of the DNA specimen, that device 1200 will have slidable cover 1210 pressed forwardly as shown in Fig.
  • absorbent 1208 35 to protect absorbent 1208 from any extraneous DNA collection or from incidental damage during transport or manipulation preparatory to use or after use.
  • extraneous DNA might be contributed to absorbent 1208 by the incidental brushing of absorbent 1208 on the body of the officer making the sample collection, or on alternate areas of mammalian remains that contain DNA, but which were not the intended area of collection for that sample.
  • device 1200 is shown with slidable cover 1210 pushed rearwardly to expose absorbent 1208 and to allow collection of a DNA specimen thereon.
  • absorbent 1208 has only a single surface exposed for collection of DNA thereon.
  • absorbent 1208 is resting upon area 1203 of holder 1202 so that absorbent 1208 is supported by area 1203 during collection activities. Due to the support of absorbent 1208 by support area 1203 during collection activities, absorbent 1208 may be relatively roughly treated during the collection of a DNA specimen without undue harm to absorbent 1208.
  • the support of absorbent 1208 by support area 1203 allows pressure to be exerted against absorbent 1208 to achieve collection of the dried blood or liquid blood from a rough surface without having to apply support pressure to the back of absorbent 1208.
  • the operator might be inclined to touch absorbent 1208 with their finger or other object to exert pressure on absorbent 1208 that might risk contamination of absorbent 1208 through the addition of extraneous DNA or other substances to absorbent 1208.
  • the option exists to simply remove handle 1216, having absorbent 1208 attached thereto, - from capture within holder 1202 to thereby allow dipping of absorbent 1208 into a liquid specimen.
  • slidable cover 1210 is closely fit between the vertical sides of flanges 1218a, 1218b to provide frictional resistance to the movement of slidable cover 1210 on handle 1216 when handle 1216 is contained within holder 1202. In this manner, frictional resistance is provided to the sliding back and forth slidable cover 1210 thereby assisting in the retention of slidable cover 1210 in any position selected by an operator using device 1200 as shown in Figs. 34 and 35 .
  • Figs. 36 and 37 the operation of device 1200 in the configuration in which holder 1202 has been removed will be described. While the configuration of device 1200 is shown in Figs. 36 - 37 , may be used during the collection of a biological sample in those cases when the attachment of holder 1202 might interfere with the sample collection or make the sample collection more difficult, the configuration shown in Figs. 36 - 37 generally is used within the clinical laboratory. When a biological specimen or sample has been collected on absorbent 1208, and the entire device shown in Figs. 34 - 35 has been shipped to a clinical laboratory for testing of the specimen, it is necessary that portions of absorbent 1208 be removed or punched from absorbent 1208.
  • portions of absorbent 1208 allows a clinical analysis to be performed on those portions removed from absorbent 1208 while retaining a portion of the biological sample on absorbent 1208 as a continuing historical and evidentiary record.
  • handle 1216 is removed from holder 1202 and sliding cover 1210 is pushed rearwardly to expose absorbent 1208 and removal of portions of 1208 can be affected by punching or cutting of a portion of the absorbent from absorbent 1208.
  • slidable cover 1210 is provided with track followers 1226a,b which move forwardly and rearwardly within tracks 1228a,b of handle 1206a,b.
  • Track followers 1226a,b are closely fit within tracks 1228a,b of handle 1206a,b and provide frictional resistance to the movement of slidable cover 1210 along tracks 1228a,b. In this manner, frictional resistance is provided to the sliding back and forth slidable cover 1210 when handle 1216 is removed from holder 1202 thereby assisting in the retention of slidable cover 1210 in any position selected by an operator using device 1200 as shown in Figs. 36 and 37 .

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EP13160889.5A 2004-04-30 2005-04-29 Support de collecte de preuves pour analyse automatique de prélèvement Expired - Lifetime EP2610010B1 (fr)

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US56708104P 2004-04-30 2004-04-30
US61710004P 2004-10-07 2004-10-07
US11/042,527 US7587793B2 (en) 2001-12-14 2005-01-25 Evidence collection holder and storage method
US11/117,502 US7597849B2 (en) 2001-12-14 2005-04-28 Evidence collection holder for sample automation
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Also Published As

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EP1758681A2 (fr) 2007-03-07
US7597849B2 (en) 2009-10-06
US20050147537A1 (en) 2005-07-07
CA2564860A1 (fr) 2005-11-17
MXPA06012474A (es) 2007-05-10
HUE031285T2 (hu) 2017-06-28
WO2005107948A2 (fr) 2005-11-17
US20050220677A1 (en) 2005-10-06
EP1758681A4 (fr) 2009-12-02
US7587793B2 (en) 2009-09-15
US20070166201A9 (en) 2007-07-19
WO2005107948A3 (fr) 2007-05-24
CA2564860C (fr) 2013-10-01
EP2610010B1 (fr) 2016-10-26

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